A number of women throughout the United States are reporting serious and potentially life-threatening health complications from Essure, a permanent form of birth control that has been believed to be fairly safe.

Essure birth control is a transcervical sterilization procedure, which is marketed as a less expensive, easier and safer alternative to tubal ligation surgery. However, hundreds of women are reporting severe Essure side effects following the procedure, causing many to opt for a hysterectomy.

The FDA has logged more than 850 reports of adverse side effects since 2004, which suggests that thousands of problems have been experienced, since it is widely acknowledged that only about 1% to 10% of all adverse events are ever reported to the FDA.

Among reports submitted to the federal regulatory agency are more than 150 Essure complications involving the device moving and puncturing fallopian tubes or the uterus, with nearly 100 women requiring hysterectomies to remove Essure birth control following severe complications. In addition, at least 150 reports have been filed involving doctors complaining of the device breaking during insertion and numerous other problems with allergic reactions and side effects.

Following increasing concerns, the FDA posted new information to their website on October 18, outlining the results of their own investigation into the Essure problems, including a review of a five-year post-approval study, complaints through the MedWatch Adverse Event Reporting System and web-based testimonials.

The FDA has acknowledged the complications experienced by a number of women, but indicates that many were seen in clinical trials and are addressed on the product’s labeling, such as pain. However, the agency did note that some of the complaints, included depression, extreme fatigue, and weight gain, were not seen during clinical trials.

“We evaluated the available clinical literature to determine what long-term complications may be associated with Essure more than five years after placement, because the post-approval study only evaluated safety and effectiveness up to five years,” the FDA review states. “To date, we have found no evidence in the literature indicating any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement.”

Essure birth control was first approved by the FDA in 2002. It was originally designed and manufactured by Conceptus, before recently acquired by the pharmaceutical giant Bayer. More than 750,000 women have undergone Essure birth control surgery, according to prior data released by Conceptus.

The birth control implant is offered as an outpatient procedure by many medical facilities. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.

In recent months, increased media attention has been focused on reported Essure problems experienced by some women, including extreme abdominal pain, excess bleeding, rashes and bloating, and having internal organs removed as a result of side effects. Some women report pieces of the device have remained lodged in the uterus following removal of Essure.

Many women have taken to social media and the internet to share and log their complaints. Some describe the pain as similar to having “daily period cramps” and others report the pain is as severe as “contractions of labor pains” where physical movement often makes the pain worsen.

The manufacturers of Essure have cited clinical studies focused on the safety of the procedure. The FDA has indicated that any women who have experienced Essure complications should submit a report to its MedWatch adverse event reporting program.

14 comments

I have had the Essure and shortly after the procedure I had experienced nothing but pure lower abdominal pain like knives stabbing me in the exact spots the coils were. The pain was so bad I gad to have them surgically removed which required my fullopian tubes to also be removed. This has been very costly. Since my tubes and coils have been removed I have still been experiencing horrible side effects physically and mentally. Still going to the doctor for help for the pain. Regret, regret, regret Essure.

I had essure put in Aug 23 2010. I have cramping heavy menstrual cycle irregular cycle irregular.passing clots back pain hot flashes fatigue sharp pains in my left side. I was tested to see if I was going into menopause I was told no. I asked my obgyn if my problems are from theeeessure I was told no. No I’m reading this and thinking I’m right. There are days I can’t get up I m in horrible pain and tired. I want theses out and don’t recommended them to anyone.

I had the procedure done 2 years ago and now I regret it. After not having a normal menstrual cycle for 9 months + I went to my doctor and was diagnosed with Polycystic Ovarian Syndrome which leads to diabetes, weight gain, and irregular menstrual cycle. And yes I’m now newly diagnose insulin resistance patient. I am facing bad news every doctor visit and regret making a bad responsible decision.

I had the Essure procedure done in March 2014 and I have expierinced menstraul like cramps on both sides of where the coils were placed. I am just assuming that this is the tubes growing in or around the coils. I had my HSG test today and sad to report that only one of my tubes is blocked so far at this point. I was hoping for a better outcome and hopefully the other tube will continue to grow around the coil. The test was uncomfortable and I would rather not take it again!

I got Essure in August 2013, at the same time I delivered my daughter by c-section. I have experienced no major problems. I do get some minor twinges that correspond with my monthly ovulation, but the side effects of Essure for me pale in comparison to what I’ve experienced with IUD’s and hormone based methods. I’m happy with Essure.

I have had the essure since 2010 I was not told of any of the side effects that it could cause. It took one of my tubes 6months to block. Now I have extreme pain on my left side, have headaches worse than ever and mood swings more now than I have had before. I have been to the er so many times for the pain to the point where they have to take me straight back and start IV pain meds just to get the pain down so I can talk to the doctor. Then its a ct, a ultra sound and blood work every time. It is not worth getting.

I had the Essure in 2008 and had nothing’s but problems ever since. Bleeding all the time or whenever I have intercourse. I have pain like someone’s stabbing me with a knife during intercourse in those areas. The pain in the exact areas where they are aches like severe cramping and sensitive to touch for several days after that. It has caused major issues in my everyday life. I have talked to my primary doctor and Gynacologist several times about this. They have checked the areas with ultrasounds and said everything else looks super healthy it has to be the Essure. The surgery to have hem removed is extremely expensive and I was told hard to find a doctor who knows how to do it.

i had the essure done in 2012 i called the doctors office over an over again after it was done an that told me i was ok that its sobest to be like that til the essure hills up i now have a cyst an tumors in me the er doctor told me i had to have it takeing out an now he will not see me becouse i have no madcare no more im in pain all day ever day i cant even go an p with out hurting please do not get this i have called the fda an others so please do not get this thank you

I got essure in 2009 after my 3rd baby. I was back to normal periods, etc. I went and got essure inserted and I had severe cramping, I had to take 1600mg of Motrin every 2 hours, because the pain was so bad. I ended up 2 years later with a partial hysterectomy because I couldn’t stand the pain anymore. I was constantly bleeding and my mood swings from the excessive bleeding was awful! The doctor that performed the procedure deployed to Iraq. I was treated on a military installation, since I was a military wife. It was the worst experience ever. I had to take for two years Motrin and a heating pad. I lived with them I couldn’t move, I couldn’t go hardly any where and I surely couldn’t exercise.

I had this procedure done in 2009, and within a few months, I was crying, and I said ” I think its these implants, I feel crazy. I actually had the procedure done, and it worked on one side and not the other. So I had to undergo this very uncomfortable procedure again, which I dreaded. The Second time was worst than first time, but it was with a different Product, but same concept. This was the Adiana. I experienced horrible cramping immediatly follwing the procedure which lasted for about an hour. I have cramping in my tubes during every cycle, and my cycles have become unbearable, lasting up to 10 days. I have experienced, major depression, fatigue, and wait gain, not to mention, the relationships I destroyed, due to Hormonal issues. A few months after this procedure, I had an issue at work, as wasn’t able to work OT, for a year . This financially destroyed me, I was behind on all my bills, and still haven’t been able to get caught up. I even told a co worker about 3 years ago, that I would not recommend this procedure. I often wonder, what happened to the other Essure implant that was inserted but didn’t work? Where did it go? How many more problems will I have to deal with, due to this ” Responsible Desision” I have made. My doctor has recommended I get a Hysterectomy, that will again financially burden me.

I have all the side effects listed , weight gain, depression, abdominal pain sometimes so severe it feels like I’m in labor, back pain, blood clots when on menstraul cycle, also the procedure only took on one side so procedure had to be done a second time , so i often wonder what happened to the other one, where did it go?

I had the coils placed in September 2006. Over the past year I have had excruciating pain in my lower abdomen, headaches and back aches every day, heavy menstrual cycles and body aches. I was rushed to the ER last week because I thought my appendix burst,I was in so much pain that I couldn’t stand. The doctor ordered a CT scan and they found that the right coil is in my uterus and that’s where the pain is coming from. I was told today that I need a complete hysterectomy. She said the surgery is a must and it’s my only option. They’re going to try to save one ovary so I don’t get early menopause. I’m devastated.

I had the essure procedure inplanted on June 25, 2014. Due to financial hardship I was unable to get the recommended xrays at the 3 month period, so I never found out if they attached properly. Since then I have experience lots of bloating almost all the time, wether on or off my cycle. Recently, the last few months I’ve noticed that my periods are much heavier, comes down with lots of blood clots and now my biggest concern is the smell! The smell of the blood from my period for the last 2 months is just awful!! I know its supposed to smell like blood but this smell is just horrible, it doesn’t matter if I’m standing, sitting or laying down, it feels like the blood is just pouring out and my periods have never smelled this bad. Now, I’m really concerned there may be something going on with the coils for this to be happening!!! I’m freaking out!!

I had the proceeer done and I been having problems I am having trouble with my sleep patterns and things I am coughing up stuff and other things moodswjngs are out of whack and my periods are not normal and tasting metalis not good either the doctors keep saying nothing is wrong but I beg to differ on that one I need help I wished I schoukd not of listened to my mom this us not safe at all it schould be taken of the market

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